Atlanta Center for Medical Research

Scope

JOB TITLE: Clinical Research Coordinator (CRC I)

GENERAL SUMMARY OF DUTIES – Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH, GCP, protocol, and ACMR guidelines, regulations, and policies; Responsible for the delegation of tasks to Research Assistants ensuring the accurate completion and maintenance of study components and duties.

MANAGER – Clinical Trial Manager

Duties

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Supervisory

  • Assessing the daily performance and productivity of designated Research Assistants
  • Delegating tasks to RA’s; ensuring goals of accuracy and timeliness are met
  • On-going education and training of RA’s regarding protocol specific tools, updates, roles, responsibilities and expectations
  • Assisting management in maintaining a positive and productive work environment
  • Other duties as assigned

STUDY COORDINATION

  • Coordinating all aspects of patient involvement from study initiation until study completion;

Study start-up:

assist in the creation of thorough and accurate source documents; * Work collaboratively with other internal departments, sponsors and investigators to ensure protocols are understood and assist in the training's of staff members * Participate in IMs and SIVs; communicating with sponsors and representatives * Ensure site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)

Screening participants for actively enrolling studies:

  • Assist in reviewing all participant history from Pre-Enrollment and Enrollment departments confirming information with potential participant and study physician
  • Educating potential participants and caregivers on protocol specific details and expectations;
  • Working with the physician to address all questions and concerns related to the trial and informed consent process;
  • Maintaining thorough knowledge of study specific inclusion/exclusion criteria

Coordinating scheduled visits and adhering to protocol visit windows and timelines:

  • Performing safety and efficacy assessments per protocol vital signs, EKGs, blood draws and other assessments as assigned
  • Collaborating with the research pharmacist to perform drug accountability and compliance at each visit and educating subject on proper dosing regimen
  • Accurate and timely completion of source documents recording subject’s participation in study
  • Communicate closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines
  • Assist investigators in collection of information from study subjects regarding AEs, concomitant medications and other changes throughout participation
  • Responsible for subject scheduling
  • Responsible for timely data entry and query resolution
  • Timely reporting of study events (SAEs, protocol deviations, etc) to appropriate departments and other outside agencies (Sponsors, CRO’s, etc.)
  • Following subjects through study completion and creating follow-up care plan with physician, study subject and primary care provider;
  • Ensuring preparation for and facilitating of all study monitoring visits and following up promptly with monitor follow-up letters Prompt and professional communication with sponsors, representatives and other study related parties
  • Maintaining professional and appropriate interactions with study subjects, caregivers, sponsors and all other study related personnel, and staff members
  • Keeping management informed of study status and any study-related issues
  • Other duties as assigned

Qualifications

KNOWLEDGE, SKILLS & ABILITIES

Demonstrated expertise in:

  • knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials
  • providing strong leadership and mentor ship to others
  • developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level
  • crisis management and problem solving; ability to react calmly and effectively in emergent situations
  • working independently as well as functioning as part of a team
  • communicating clearly both written and verbally

Highly proficient in:

  • the use of technology required for the completion of study visits and study conduct
  • completing paperwork with precision, accuracy, and attention to detail
  • meeting timelines and attention to detail
  • prioritizing daily tasks with minimal guidance
  • using medical equipment and instruments to administer study subject care

Established skill in:

  • basic clinical skills to obtain patient safety measures (measure pulse, respiration rate, blood pressure, EKG, height and weight, draw and process blood samples)
  • medical terminology

EDUCATION

  • BA/BS preferred or 2 years’ experience in clinical research

EXPERIENCE

*1-2 years’ experience in the clinical research field required; at least 1 year of direct patient and sponsor interaction;

CERTIFICATE/LICENSE – CPR training provided; other training provided on an as needed basis

PHYSICAL DEMANDS/WORKING CONDITIONS – Standard operating hours are Monday through Friday, 8:00 a.m. to 4:30 p.m. CRC’s are often required to see patients or complete job-related tasks outside of that time frame, in excess of a standard 40-hour work week. Requires prolonged walking, standing, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-born pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities and medical/psychiatric diagnoses disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.

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